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Innovation in gene therapy brings the potential for transforming patient care and obviating the need for chronic therapy through single-dose cures. Despite the potential long-term benefits of this new therapeutic modality, gene therapy companies face a number of underappreciated challenges.

Since the introduction of similar biological medicinal products in the EU in 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the United States. How does the rise of the China biosimilars market fit into this established picture?

The latest version of ISO 13485 already contains several requirements that do not exist in 21 CFR 820. In advance of the new proposed rule’s release, this article presents a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final.

On March 5, 2019, Representative Anna Eshoo (D-CA) introduced H.R. 1520, the “Purple Book Continuity Act of 2019.” The bill addresses the availability of information about approved biological products that may support the development of biosimilar products. It has five cosponsors in the House, drawn from both sides of the aisle, and was considered with five other bills by the House Energy and Commerce Committee on April 3, 2019. The Committee advanced the bill, along with five others, as a step toward addressing runaway drug pricing.

The guidance looks at what constitutes a manufacturing site change, when a manufacturer should submit a PMA supplement, what documentation should be submitted to the FDA with a site change supplement, and more.

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has published technology roadmaps addressing needs and gaps in three key product areas: gene therapy, antibody-dug conjugates, and vaccines. The roadmaps were developed with the collaborative input of industry, academic, and government experts. This article highlights technology opportunities for gene therapy manufacturing.

Since 2012, patent stakeholders in the U.S. have faced remarkable uncertainty in the evaluation of patent subject matter eligibility under 35 U.S.C. 101, particularly in the application of the Supreme Court’s Alice/Mayo1 test by the United States Patent and Trademark Office (USPTO).

The United Kingdom’s plan to leave the European Union has devolved into a mess of shifting deadlines and what-ifs. Here, Zaid Al-Nassir breakdown for medtech leaders has been updated to include events taking place through April 11, 2019.